QUIDEL MOLECULAR INFLUENZA A + B ASSAY

K131728 · Quidel Corp. · OZE · Aug 29, 2013 · Microbiology

Device Facts

• Record ID: K131728
• Device Name: QUIDEL MOLECULAR INFLUENZA A + B ASSAY
• Applicant: Quidel Corp.
• Product Code: OZE · Microbiology
• Decision Date: Aug 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3980
• Device Class: Class 2

Intended Use

The Quidel® Molecular Influenza A+B assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay does not detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2011 and 2013 influenza seasons when influenza A/H3 and 2009 H1N1 influenza were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. The assay can be performed using either the Life Technologies QuantStudio™ Dx, the Applied Biosystems® 7500 Fast Dx (ABI 7500), or the Cepheid SmartCycler® II.

Device Story

The Quidel Molecular Influenza A+B Assay is a multiplex real-time RT-PCR test for detecting influenza A and B viral RNA. Input samples are nasal or nasopharyngeal swabs; nucleic acids are extracted using the NucliSENS easyMAG platform. The assay uses a lyophilized Master Mix containing primers and dual-labeled fluorescent probes (TaqMan chemistry) targeting conserved regions of the influenza A matrix protein gene and influenza B neuraminidase gene. Amplification and detection are performed on the Life Technologies QuantStudio Dx, Applied Biosystems 7500 Fast Dx, or Cepheid SmartCycler II. The process includes a Process Control (PRC) to monitor for inhibitors and extraction efficiency. The instrument generates fluorescent signals proportional to target amplification; software interprets these signals to report positive or negative results. Used in clinical laboratories by trained personnel to aid in differential diagnosis of respiratory infections. Results assist clinicians in patient management and treatment decisions.

Clinical Evidence

Prospective clinical study (n=619 evaluable specimens) compared Quidel Molecular Influenza A+B on QuantStudio Dx against an FDA-cleared molecular comparator. Influenza A: 100% PPA (204/204), 92.0% NPA (382/415). Influenza B: 99.1% PPA (106/107), 98.0% NPA (502/512).

Technological Characteristics

Multiplex real-time RT-PCR; TaqMan chemistry; uses FAM (Flu A), VIC (Flu B), and CY5 (Process Control) reporter dyes. Lyophilized Master Mix. Platform: Life Technologies QuantStudio Dx. Extraction: bioMérieux NucliSENS easyMAG. Closed-tube reaction.

Indications for Use

Indicated for qualitative detection and differentiation of influenza A and B viral RNA in nasal and nasopharyngeal swabs from symptomatic patients. For prescription use only.

Regulatory Classification

Identification

A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B; (2) Influenza A subtype H1 and Influenza A subtype H3; (3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B; (4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus; (5) Human Metapneumovirus; (6) Rhinovirus; and (7) Adenovirus.

Special Controls

*Classification.* Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;” (2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and (3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.

Predicate Devices

• Quidel Molecular Influenza A+B Assay (K112172, K113777)
• Prodesse ProFlu+ (K092500)

Submission Summary (Full Text)

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K131728

Quidel Molecular Influenza A + B Assay 8/26/2013 Page 1 of 16

#### 510(k) Summary

#### Applicant:

Quidel Corporation 10165 McKellar Court San Diego, California 92121 Telephone: [phone] Fax: [phone]

#### Contact Information:

Ronald H. Lollar, Senior Director Clinical and Regulatory Affairs 1055 East State Street Suite 100 Athens, Ohio 45701 740-589-3300 - Corporate number 740-589-3373 - Desk phone [phone] - Fax [e-mail]

# AUG 2 9 2013

#### Date of preparation of 510(k) summary:

June 11, 2013

#### Device Name:

Trade name - Quidel Molecular Influenza A + B Assav Classification name - Respiratory viral panel multiplex nucleic acid assay Product Code - OZE Subsequent Product Code - OOI Regulation - 21 CFR 866.3980 Classification - Class II

## Device Description:

The Quidel Molecular Influenza A+B Assay detects viral nucleic acids that have been extracted from a patient sample using the NucliSENS® easyMAG® automated extraction platform. A multiplex real-time RT-PCR reaction is carried out under optimized conditions in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing the Life Technologies QuantStudio™ Dx, the Applied Biosystems® 7500 Fast Dx, or the Cepheid SmartCycler® II platform. Identification of influenza A occurs by the use of target specific primers and a fluorescentlabeled probe that hybridizes to a conserved influenza A sequence within the matrix protein gene. Identification of influenza B occurs by the use of target specific primers and fluorescent-fabeled probes that will hybridize to a conserved influenza B sequence within the neuraminidase gene.

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Ouidel Molecular Influenza A + B Assay

The following is a summary of the procedure:

- 1. Sample Collection: Obtain nasal swab and nasopharyngeal swab specimens using standard techniques from symptomatic patients. These specimens are transported, stored, and processed according to established laboratory procedures.
- 2. Nucleic Acid Extraction: Extract Nucleic Acids from the specimens with the NucliSENS® easyMAG® System following the manufacturer's instructions using the appropriate reagents.

Prior to the extraction procedure add 20 uL of the Process Control (PRC) to each 180 uL aliquot of specimen. The PRC serves to monitor inhibitors in the extracted specimen, assures that adequate amplification has taken place and that nucleic acid extraction was sufficient.

- 3. Rehydration of Master Mix: Rehydrate the lyophilized Master Mix using 135uL of Rehydration Solution. The Master Mix contains oligonucleotide primers, fluorophore and quencher-labeled probes targeting highly conserved regions of the influenza A and influenza B viruses as well as the process control sequence. The primers are complementary to highly specific and conserved regions in the genome of these viruses. The probes are dual labeled with a reporter dye attached to the 5-end and a quencher attached to the 3' -end. The rehydrated Master Mix is sufficient for eight reactions.
- 4. Nucleic Acid Amplification and Detection: Add 15 uL of the rehydrated Master Mix to each reaction tube or plate well. 5 uL of extracted nucleic acids (specimen with PRC) is then added to the reaction tube or plate well. Place the tube into the Cepheid SmartCycler® II instrument, or place the plate into either the Applied Biosystems® 7500 Fast Dx instrument or Life Technologies QuantStudioTM Dx.

Once the reaction tube or plate is added to the instrument, the assay protocol is initiated. This protocol initiates reverse transcription of the RNA targets generating complementary DNA, and the subsequent amplification of the target sequences occurs. The Quidel Molecular Influenza A+B Assay is based on TaqMan® chemistry, and uses an enzyme with reverse transcriptase, DNA polymerase, and 5'-3' exonuclease activities. During DNA amplification, this enzyme cleaves the probe bound to the complementary DNA sequence, separating the quencher dye from the reporter dye. This step generates an increase in fluorescent signal upon excitation by a light source of the appropriate wavelength. With each cycle, additional dye molecules are separated from their quenchers resulting in additional signal. If sufficient

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| 510(k) Summary | Quidel Molecular Influenza A + B Assay |
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| | 8/26/2013 |
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fluorescence is achieved the sample is reported as positive for the detected target sequence

## Intended Use:

The Quidel Molecular Influenza A+B Assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections in humans in conjunction with clinical and epidemiological risk factors. The assay does not detect the presence of influenza C virus.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Performance characteristics for influenza A were established during the 2011 and 2013 influenza seasons when influenza A/H3 and 2009 H1N1 influenza were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The assay can be performed using the Life Technologies OuantStudio™ Dx. the Applied Biosystems® 7500 Fast Dx, or the Cepheid SmartCycler® II.

## Conditions for Use:

For prescription use only.

## Device Comparison

The Quidel Molecular Influenza A+B Assay was compared to Prodesse ProFlu+ ("Comparator Device"). The characteristics of Quidel Molecular Influenza A+B Assay ("Subject Device") and the two predicates. Quidel Molecular Influenza A+B Assay (previously cleared for use with two other instruments) and the Prodesse ProFlu+ are described in the table below:

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| Device Comparison | | | | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Item | Subject Device<br>Quidel Molecular<br>Influenza A+B Assay | Comparator Device<br>Quidel Molecular<br>Influenza A+B Assay<br>(k112172, k113777) | Comparator Device<br>Prodesse ProFlu+<br>(k092500) | |
| Intended Use | The Quidel Molecular<br>Influenza A+B Assay<br>is a multiplex Real<br>Time RT-PCR assay<br>for the <i>in vitro</i><br>qualitative detection<br>and differentiation of<br>influenza A and<br>influenza B viral RNA<br>in nasal and<br>nasopharyngeal swabs<br>from patients with<br>signs and symptoms<br>of respiratory<br>infection. This test is<br>intended for use as an<br>aid in the differential<br>diagnosis of influenza<br>A and influenza B<br>viral infections in<br>humans in<br>conjunction with<br>clinical and<br>epidemiological risk<br>factors. The assay<br>does not detect the<br>presence of influenza<br>C virus.<br><br>Negative results do<br>not preclude influenza<br>virus infection and<br>should not be used as<br>the sole basis for<br>diagnosis, treatment<br>or other patient | The Quidel Molecular<br>Influenza A+B Assay<br>is a multiplex Real<br>Time RT-PCR assay<br>for the <i>in vitro</i><br>qualitative detection<br>and differentiation of<br>influenza A and<br>influenza B viral RNA<br>in nasal and<br>nasopharyngeal swabs<br>from patients with<br>signs and symptoms<br>of respiratory<br>infection. This test is<br>intended for use as an<br>aid in the differential<br>diagnosis of influenza<br>A and influenza B<br>viral infections in<br>humans in<br>conjunction with<br>clinical and<br>epidemiological risk<br>factors. The assay<br>does not detect the<br>presence of influenza<br>C virus.<br><br>Negative results do<br>not preclude Influenza<br>virus infection and<br>should not be used as<br>the sole basis for<br>diagnosis, treatment<br>or other patient | The ProFluTM+ Assay<br>is a multiplex Real-<br>Time PCR (RT-PCR)<br><i>in vitro</i> diagnostic<br>test for the rapid and<br>qualitative detection<br>and discrimination of<br>Influenza A Virus,<br>Influenza B Virus,<br>and Respiratory<br>Syncytial Virus<br>(RSV) nucleic acids<br>isolated and purified<br>from nasopharyngeal<br>(NP) swab specimens<br>obtained from<br>symptomatic patients.<br>This test is intended<br>for use to aid in the<br>differential diagnosis<br>of Influenza A,<br>Influenza B and RSV<br>viral infections in<br>humans and is not<br>intended to detect<br>Influenza C.<br><br>Negative results do<br>not preclude<br>influenza or RSV<br>virus infection and<br>should not be used as<br>the sole basis for<br>treatment or other<br>management<br>decisions. It is | |
| Device Comparison | | | | |
| Item | Subject Device<br>Quidel Molecular<br>Influenza A+B Assay | Comparator Device<br>Quidel Molecular<br>Influenza A+B Assay<br>(k112172, k113777) | Comparator Device<br>Prodesse ProFiu+<br>(k092500) | |
| | decisions. | decisions. | negative RSV results | |
| | Performance | Performance | be confirmed by | |
| | characteristics for | characteristics for | culture. | |
| | influenza A were | influenza A were | Performance | |
| | established during the | established during the | characteristics for | |
| | 2011 and 2013 | 2011 influenza season | Influenza A Virus | |
| | influenza seasons | when influenza A/H3 | were established | |
| | when influenza A/H3 | and 2009 H1N1 | when Influenza A/H3 | |
| | and 2009 H1N1 | influenza were the | and A/H1 were the | |
| | influenza were the | predominant influenza | predominant | |
| | predominant influenza | A viruses in | Influenza A viruses | |
| | A viruses in | circulation. When | in circulation. When | |
| | circulation. When | other influenza A | other Influenza A | |
| | other influenza A | viruses are emerging, | viruses are emerging, | |
| | viruses are emerging, | performance | performance | |
| | performance | characteristics may | characteristics may | |
| | characteristics may | vary. | vary. | |
| | vary. | If infection with a | If infection with a | |
| | If infection with a | novel influenza A | novel Influenza A | |
| | novel influenza A | virus is suspected | virus is suspected | |
| | virus is suspected | based on current | based on current | |
| | based on current | clinical and | clinical and | |
| | clinical and | epidemiological | epidemiological | |
| | epidemiological | screening criteria | screening criteria | |
| | screening criteria | recommended by | recommended by…